Single-Use System Supports a Freeze/Thaw Platform Capable of Providing an End-to-End Solution for Fluid Drug Substance Inter-Facility Storage and Delivery

Single-Use System Supports a Freeze/Thaw Platform Capable of Providing an End-to-End Solution for Fluid Drug Substance Inter-Facility Storage and Delivery

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Single-Use System Supports a Freeze/Thaw Platform Capable of Providing an End-to-End Solution for Fluid Drug Substance Inter-Facility Storage and Delivery

04/02/2019, 2:15 PM - 3:00 PM

Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall

Language:

English

The inter-facility management of freeze/thaw processes of drug substances has been a challenge fraught with issues that affect sites around the globe. Drug manufacturers often utilize containers unsuitable for repeated freeze/thaw cycles, while also utilizing equipment that lacks controlled freeze/thaw rates, which can lead to protein aggregation and denaturation. A freeze/thaw platform solution designed to overcome the challenges related to both internally-developed and commercially-available first-generation single-use system solutions on the market, will be presented. This novel end-to-end (E2E) freeze/thaw platform improves the freezing, shipping and thawing of bulk drug substances. This platform includes material handling, shipping and post-thaw mixing components, and the single-use, scalable rigid containers that work in harmony to render a robust freeze/thaw processes for commercial and clinical scales, which will be detailed. Includes a case study.

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